NCT04129619 is a Phase 2 clinical trial of ORP-101 in Irritable Bowel Syndrome With Diarrhea, sponsored by OrphoMed, Inc..

Who is sponsoring NCT04129619?

NCT04129619 is sponsored by OrphoMed, Inc..

What drugs are being tested in NCT04129619?

Interventions in NCT04129619: ORP-101, Placebo.

What condition does NCT04129619 study?

NCT04129619 studies Irritable Bowel Syndrome With Diarrhea.

Is NCT04129619 still recruiting?

NCT04129619 is currently completed. Last updated 4 March 2022.

Last reviewed 2022-03-04 · How we verify

NCT04129619

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

Completed Phase 2 Last updated 4 March 2022

What this trial tests

Phase 2 trial testing ORP-101 in Irritable Bowel Syndrome With Diarrhea in 321 participants. Completed in 4 October 2021.

Timeline

22 November 2019

Primary endpoint
4 October 2021

4 October 2021

Quick facts

Lead sponsor	OrphoMed, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	321
Start date	22 November 2019
Primary completion	4 October 2021
Estimated completion	4 October 2021
Sites	74 locations across United States

Drugs / interventions tested

ORP-101 — full drug profile →
Placebo

Conditions studied

Irritable Bowel Syndrome With Diarrhea — all drugs for Irritable Bowel Syndrome With Diarrhea →

Sponsor

OrphoMed, Inc.

Who can join

Adults 18 to 75, any sex, with Irritable Bowel Syndrome With Diarrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the effects of ORP-101 versus placebo on stool consistency and abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). It will also assess the safety and tolerability of ORP-101 in patients with IBS-D.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

ORP-101 in Irritable Bowel Syndrome With Diarrhea: A Phase II Randomized, Controlled Trial.
Singh P, Nee JW, Ballou S, Lee A, et al · · 2026 · PMID 41887552 · DOI 10.1016/j.cgh.2026.03.012

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04129619 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by OrphoMed, Inc.
Last refreshed: 4 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04129619.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing